Salivary metabolic biomarkers for human oral cancer detection

Abstract

The present invention provides a novel oral cancer and periodontal disease salivary metabolome for use in the diagnosis or for providing a prognosis for oral cancer and periodontal disease in an individual. The present invention also provides novel methods of diagnosing or providing a prognosis for oral cancer or periodontal disease by detecting metabolites found in the saliva of an individual. Finally, the present invention provides kits for the detection of salivary metabolites useful in the diagnosis or prognosis of oral cancer and periodontal disease in an individual.

1 . A method of diagnosing or providing a prognosis for an oral disease in an individual, the method comprising the steps of:
 (a) determining the level in a salivary sample from the individual of at least one salivary oral disease metabolite biomarker selected from those found in Table 2; and   (b) determining if the level of said at least one metabolite corresponds to a level found in an oral disease metabolome profile, thereby diagnosing or providing a prognosis for oral disease.   
   
   
       2 . The method of  claim 1 , wherein said oral disease is oral cancer or periodontal disease. 
   
   
       3 . The method of  claim 1 , wherein the level of said at least one salivary oral disease metabolite biomarker is determined by using a technique selected from the group comprising HPLC, TLC, electrochemical analysis, capillary electrophoresis, mass spectrometry, refractive index spectroscopy (RI), Ultra-Violet spectroscopy (UV), fluorescent analysis, gas chromatography (GC), radiochemical analysis, Near-InfraRed spectroscopy (Near-IR), Nuclear Magnetic Resonance spectroscopy (NMR), and light scattering analysis (LS). 
   
   
       4 . The method of  claim 1 , wherein step (b) comprises the sub-steps of:
 comparing the level of said at least one metabolite to a first profile comprising an oral disease metabolic profile;   (ii) comparing the level of said at least one metabolite to a second profile comprising a control metabolic profile; and   (iii) determining which metabolic profile is most similar to the level of said at least one metabolite from said individual, thereby diagnosing said individual as either having or not having an oral disease.   
   
   
       5 . The method of  claim 4 , further comprising the step of comparing the level of said at least one metabolite to a third profile comprising a periodontal disease metabolic profile. 
   
   
       6 . A method of identifying a salivary oral disease metabolite biomarker, the method comprising the steps of:
 (a) determining the level of a metabolite in a first saliva sample from an individual with oral disease;   (b) comparing the level of said biomarker to the level of the same biomarker in a second saliva sample from an individual without oral disease; and   (c) determining if the level of the metabolite in said first sample is different from the level of the metabolite in said second sample, thereby identifying a salivary oral disease metabolite biomarker.   
   
   
       7 . A kit for use in diagnosing or providing a prognosis for oral disease in an individual, the kit comprising at least one reagent for detecting a metabolite selected from those found in Table 2.